Address
Form of workJob Description:
The Director, Lifecycle Management will develop and ensure project management and deliver product design expertise to address new markets, continuous and quality improvements, regulatory changes, efficiencies across the Implant Network, production transfers, phase-out(s), synergies with the businesses, and unplanned events or disruptions while serving as core Leader of Product Focus Teams (PFT) with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.
How You Will Make An Impact:
• Manage strategic to enterprise-wide programs and initiatives (e.g., Product Focus Team (PFT), process equipment and automation programs) for ongoing global continuity of quality supply for commercial products as well as upstream during the product development process . Ensure appropriate Global Supply Chain (GSC) integration into product Lifecycle Management through collaboration with R&D, Marketing, Quality, and Regulatory Affairs, and downstream with the manufacturing and other critical GSC functions to ensure alignment of objectives and activities. Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN), lead the facilitation of the overall project strategy and implement some changes as appropriate.
• Provide innovative solutions to complex manufacturing issues in specialized areas, internal or external, to ensure adequate business continuity and to guarantee the highest level of quality and service to customers to safeguard the medical product design (materials, tissues, delivery systems, and electro-mechanical devices) and manufacturing intent from suppliers through distribution
• Provide direction and guidance to project teams to execute larger Supply Chain projects and/or initiatives
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews to align with the key project milestones
• Create a cross-functional environment and governance that fosters a rapid response for change control
• Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes
• Ensure successful integration of process technologies or transfer of stabilized products into and between Edwards Commercial Manufacturing facilities and External Manufacturers by working closely with the business partners from those areas. Continue to drive product launches into additional markets. Ensure risks and mitigations are known to stakeholders and Senior Leadership. Define and facilitate the synergies with the Business Unites (BUs) and the manufacturing sites.
• Establish, provide complex analyses, and track progress against agreed upon key business and operating metrics. Develop executive summaries, and recommendations to facilitate strategic decision making and gain buy-in from Senior Management in support of new projects, initiatives, and/or programs to ensure adequate business continuity. Escalate program risk to management when (e.g., LCM, process equipment implementation) projects are not executed successfully or do not deliver anticipated outcomes.
• Partner with Finance to anticipate and quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case with plan to maintain or improve profitability.
• Other incidental duties: Review and approval of Product Lifecycle Management file updates
What You'll Need:
• Bachelor's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 12 years of experience in providing technical engineering support in medical device manufacturing.
• Demonstrated track record successfully commercializing and sustaining medical devices throughout the end-to-end supply chain.
• Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions preferred. Ability to set clear expectations and orchestrate all activities in those areas.
span of influence and control.
What Else We Look For:
• Master's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 11 years of experience in providing technical engineering support in medical device manufacturing.
• Doctorate/PhD in engineering, preferably Mechanical, or Manufacturing Engineering and 8 years of experience in providing technical engineering support in medical device manufacturing.
• Strong Technical knowledge and leadership in the area of manufacturing engineering of medical devices including process excellence methodologies such as Six Sigma, cGMP, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, ergonomics, GD&T, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering.
• Expert in knowledge of Design Control for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implants, electro-mechanical devices
• Strong cross-functional leadership and influencing skills (without direct line of authority) with the ability to build global strategic partnerships across the organization
Experience leading cross-functional teams without direct line reporting authority required.
• Demonstrated skills in technical file updates
• Proven successful project management skills, including the development and management of dashboard required. Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving, analytical, and critical thinking skills
• Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM, Ignite)
• Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders.
• Expert understanding of advanced processes and equipment used to manufacture medical devices.
• Knowledge of financial budgeting and acumen to make financial and technical based recommendations to the business
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on projects within multiple areas, interfacing with project managers, cross-functional teams and middle management
• Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence and control.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $141,000 to $200,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
The Director, Lifecycle Management will develop and ensure project management and deliver product design expertise to address new markets, continuous and quality improvements, regulatory changes, efficiencies across the Implant Network, production transfers, phase-out(s), synergies with the businesses, and unplanned events or disruptions while serving as core Leader of Product Focus Teams (PFT) with the business objectives to maintain a leading position in the medical device market across surgical and trans-catheter businesses.
How You Will Make An Impact:
• Manage strategic to enterprise-wide programs and initiatives (e.g., Product Focus Team (PFT), process equipment and automation programs) for ongoing global continuity of quality supply for commercial products as well as upstream during the product development process . Ensure appropriate Global Supply Chain (GSC) integration into product Lifecycle Management through collaboration with R&D, Marketing, Quality, and Regulatory Affairs, and downstream with the manufacturing and other critical GSC functions to ensure alignment of objectives and activities. Provide engineering expertise including business excellence methods (e.g. Six Sigma and LEAN), lead the facilitation of the overall project strategy and implement some changes as appropriate.
• Provide innovative solutions to complex manufacturing issues in specialized areas, internal or external, to ensure adequate business continuity and to guarantee the highest level of quality and service to customers to safeguard the medical product design (materials, tissues, delivery systems, and electro-mechanical devices) and manufacturing intent from suppliers through distribution
• Provide direction and guidance to project teams to execute larger Supply Chain projects and/or initiatives
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews to align with the key project milestones
• Create a cross-functional environment and governance that fosters a rapid response for change control
• Ensure Manufacturing Readiness Reviews occur in advance of major builds following operations changes
• Ensure successful integration of process technologies or transfer of stabilized products into and between Edwards Commercial Manufacturing facilities and External Manufacturers by working closely with the business partners from those areas. Continue to drive product launches into additional markets. Ensure risks and mitigations are known to stakeholders and Senior Leadership. Define and facilitate the synergies with the Business Unites (BUs) and the manufacturing sites.
• Establish, provide complex analyses, and track progress against agreed upon key business and operating metrics. Develop executive summaries, and recommendations to facilitate strategic decision making and gain buy-in from Senior Management in support of new projects, initiatives, and/or programs to ensure adequate business continuity. Escalate program risk to management when (e.g., LCM, process equipment implementation) projects are not executed successfully or do not deliver anticipated outcomes.
• Partner with Finance to anticipate and quantify budget need to support programs and initiatives including project resources, expenses and capital expenditures to support project execution. Provide Operations input and assumptions into the financial business case with plan to maintain or improve profitability.
• Other incidental duties: Review and approval of Product Lifecycle Management file updates
What You'll Need:
• Bachelor's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 12 years of experience in providing technical engineering support in medical device manufacturing.
• Demonstrated track record successfully commercializing and sustaining medical devices throughout the end-to-end supply chain.
• Experience in multiple areas of Supply Chain such as Suppliers, Manufacturing, and/or Distribution and other functions preferred. Ability to set clear expectations and orchestrate all activities in those areas.
span of influence and control.
What Else We Look For:
• Master's degree in engineering, preferably Mechanical, or Manufacturing Engineering and 11 years of experience in providing technical engineering support in medical device manufacturing.
• Doctorate/PhD in engineering, preferably Mechanical, or Manufacturing Engineering and 8 years of experience in providing technical engineering support in medical device manufacturing.
• Strong Technical knowledge and leadership in the area of manufacturing engineering of medical devices including process excellence methodologies such as Six Sigma, cGMP, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, ergonomics, GD&T, supplier development and process validation. Understand principles, theories, and concepts relevant to Engineering.
• Expert in knowledge of Design Control for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implants, electro-mechanical devices
• Strong cross-functional leadership and influencing skills (without direct line of authority) with the ability to build global strategic partnerships across the organization
Experience leading cross-functional teams without direct line reporting authority required.
• Demonstrated skills in technical file updates
• Proven successful project management skills, including the development and management of dashboard required. Ability to manage competing priorities in a fast-paced environment.
• Excellent problem-solving, analytical, and critical thinking skills
• Proven expertise in both Microsoft Office Suite and manufacturing systems (e.g. PLM, Ignite)
• Excellent ability to translate highly complex and technical information to all levels of the organizations including executive leaders.
• Expert understanding of advanced processes and equipment used to manufacture medical devices.
• Knowledge of financial budgeting and acumen to make financial and technical based recommendations to the business
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on projects within multiple areas, interfacing with project managers, cross-functional teams and middle management
• Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence and control.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $141,000 to $200,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
